Lipodissolve Treatments Need Regulation, More Study
Clinical Trial on Mesotherapy AnnouncedORLANDO, FL (April 21, 2006) — The American Society for Aesthetic Plastic Surgery (ASAPS) today announced the commencement of a double-blind placebo study of mesotherapy. The announcement was made at the Aesthetic Society’s Annual Meeting, taking place April 21-25 in Orlando, FL. Mesotherapy, which is known in the United States as the “fat dissolving” treatment Lipodissolve, involves the injection of various compounds into the skin. However, the absence of proper protocols and regulation of mesotherapy may put patients at risk. The goal of the ASAPS’ clinical trial is to give physicians and their patients more specific and standardized protocols for the use of mesotherapy as well as a basis for understanding the risks and possible benefit of this reported fat dissolving treatment. The study was designed by the Aesthetic Society and was funded by the Aesthetic Surgery Education and Research Foundation (ASERF). “Our goal is to provide physicians and their patients with the information they need to make good decisions. Currently we cannot endorse the injection of phosphatidylcholine, sodium deoxycholate, or any other drugs, vitamins, plant extracts or hormones into subcutaneous fat as practiced in mesotherapy/Lipodissolve treatments because we don’t have enough clinical data or FDA approval to support their use,” said Mark Jewell, MD, President of ASAPS. “Hopefully the ASAPS/ASERF study will answer the questions our members have about the safety and efficacy of mesotherapy.” Developed as a separate medical specialty in France in 1952, mesotherapy is a controversial method of breaking down fat cells, or in common vernacular, “melting fat.” The procedure has gained recognition in America through advertising and its use for weight loss purposes by high profile public figures. The Society’s Mesotherapy Committee developed the research protocol for the mesotherapy study, with ASERF providing the funding. The formula used for injections in the study is one that has shown the most promise in small, published trials. The study will commence in the spring of 2006 and the results will be analyzed and published in the Aesthetic Surgery Journal, the peer-reviewed journal of the American Society for Aesthetic Plastic Surgery. “This study is long overdue. It is a great start to improving patient safety in this arena,” said V. Leroy Young, M.D., chief investigator for the study and Associate Editor of the Aesthetic Surgery Journal. “It is also a testimony to the commitment aesthetic plastic surgeons have shown toward using our resources to improve the way we practice medicine and the importance we place on the safety of our patients.” Patients seeking fat dissolving treatments should be educated about the lack of clinical data to support these treatments and cautioned to wait until there is reliable information to guide their decision. Patients should also be warned about seeking treatments from people who may not be qualified to administer the large numbers of injections, which require very precise placement, involved in mesotherapy. Many mesotherapy treatment centers are opening around the country. These treatment centers are not necessarily staffed by knowledgeable and fully-trained professionals. “There has been a lot of controversy and confusion surrounding mesotherapy, much of it because all we have for information is a few small studies and anecdotal evidence. Research about mesotherapy must continue. That is why we have funded this important study. The more facts we have at our disposal, the more completely we can inform our patients and help ensure their safety,” said Jeffrey Lang, MD, President of ASERF.
According to the 2005 Aesthetic Society Cosmetic Surgery Statistics, mesotherapy was performed last year on 4,773 Americans. This is the first year statistics on this procedure were collected. -###- Study designers and chief investigators are available for interviews. Please contact the ASAPS communications staff.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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